FDA.reportPublic FDA data

Gabapentin

Product NDC
64380-754
11-digit product format
643800754
Labeler code
64380
Product ID
64380-754_66c3584b-21d1-450a-8bfe-ba096129b91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA206943
Marketing category
ANDA
Marketing start
2025-01-08
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-754-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1002
64380-754-02Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-754-01EA - Each64380-754b19be9a1-dd9b-467f-9d5a-b4b6e992f6fa12025-08-11
64380-754-02EA - Each64380-7547300b0c3-3e49-4214-8299-5704a42681e312025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-754GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]2Current NDC, 2 package rows20250131_798575b9-ddfa-4915-9574-626abbaf025f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310431gabapentin 300 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310432gabapentin 400 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310430gabapentin 100 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3
310431gabapentin 300 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3
310432gabapentin 400 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-754-0164380075401100 CAPSULE in 1 BOTTLE, PLASTIC (64380-754-01) 100 capsule2025-01-08NoNoHistorical
64380-754-0264380075402500 CAPSULE in 1 BOTTLE, PLASTIC (64380-754-02) 500 capsule2025-01-08NoNoHistorical